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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05062291




Registration number
NCT05062291
Ethics application status
Date submitted
21/09/2021
Date registered
30/09/2021

Titles & IDs
Public title
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Scientific title
Prospective, Multicenter, Observational Study to Evaluate the Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion Within the Dialysis Outflow Circuit of an Arteriovenous (AVF) Fistula or AV Graft (AVG) (The WRAP Registry)
Secondary ID [1] 0 0
CVO-P4-21-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Stenosis 0 0
Venous Occlusion 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Merit WRAPSODY Endovascular Stent Graft

Treatment: Devices: Merit WRAPSODY Endovascular Stent Graft
Target Lesion Primary Patency (TLPP)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
Proportion of subjects with Target Lesion Primary Patency
Timepoint [1] 0 0
12 and 24 months
Secondary outcome [2] 0 0
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Timepoint [2] 0 0
6, 12 and 24 months
Secondary outcome [3] 0 0
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Timepoint [3] 0 0
6, 12 and 24 months
Secondary outcome [4] 0 0
Rates of procedure- and device-related adverse events
Timepoint [4] 0 0
Index procedure, 30 days, and months 6

Eligibility
Key inclusion criteria
1. Subject provides written informed consent for study participation.
2. Subject is male or female, with an age = 18 years at date of enrollment.
3. Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 24 months.
4. Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon
5. The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session.
6. Subject has stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft and is treated with WRAPSODY Endoprosthesis System in accordance with device instructions for use.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has a planned surgical revision of access site.
2. Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
3. Subject has an uncorrectable coagulation disorder.
4. Known hypersensitivity to nickel titanium alloy.
5. Subject's hemodialysis access is anticipated to be abandoned within 6 months.
6. Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure.
7. Full expansion of a Percutaneous Transluminal Angioplasty (PTA) balloon cannot be achieved during predilatation.
8. Device would be placed in the Superior Vena Cava
9. Any inflow or outflow lesion that could jeopardize patency access long-term beyond the target treatment area.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment hospital [2] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Liverpool
Recruitment postcode(s) [4] 0 0
- Murdoch
Recruitment postcode(s) [5] 0 0
- Nedlands
Recruitment postcode(s) [6] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Belo Horizonte
Country [2] 0 0
Brazil
State/province [2] 0 0
Brasília
Country [3] 0 0
Brazil
State/province [3] 0 0
Campinas
Country [4] 0 0
Brazil
State/province [4] 0 0
Curitiba
Country [5] 0 0
Brazil
State/province [5] 0 0
Londrina
Country [6] 0 0
Brazil
State/province [6] 0 0
Niterói
Country [7] 0 0
Brazil
State/province [7] 0 0
Parnana
Country [8] 0 0
Brazil
State/province [8] 0 0
Porto Alegre
Country [9] 0 0
Brazil
State/province [9] 0 0
Recife
Country [10] 0 0
Brazil
State/province [10] 0 0
Rio De Janeiro
Country [11] 0 0
Brazil
State/province [11] 0 0
Rio de Janeiro
Country [12] 0 0
Brazil
State/province [12] 0 0
Salvador
Country [13] 0 0
Brazil
State/province [13] 0 0
Sao Paulo
Country [14] 0 0
Brazil
State/province [14] 0 0
São Paulo
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Cologne
Country [17] 0 0
Greece
State/province [17] 0 0
Río
Country [18] 0 0
Israel
State/province [18] 0 0
Jerusalem
Country [19] 0 0
Italy
State/province [19] 0 0
Pavia
Country [20] 0 0
Netherlands
State/province [20] 0 0
Maastricht
Country [21] 0 0
New Zealand
State/province [21] 0 0
Auckland
Country [22] 0 0
New Zealand
State/province [22] 0 0
Christchurch
Country [23] 0 0
New Zealand
State/province [23] 0 0
Hamilton
Country [24] 0 0
Portugal
State/province [24] 0 0
Coimbra
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Belfast
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Birmingham
Country [27] 0 0
United Kingdom
State/province [27] 0 0
London
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Oxford
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Reading

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merit Medical Systems, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dheeraj Rajan, MD
Address 0 0
University of Toronto
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Christopher Weeks
Address 0 0
Country 0 0
Phone 0 0
+1-385-766-9138
Fax 0 0
Email 0 0
christopher.weeks@merit.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05062291